Neo-adjuvant and/or Adjuvant Subcutaneous Trastuzumab (Herceptin
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Immunological
/ administration & dosage
Biomarkers, Tumor
Breast Neoplasms
/ drug therapy
Chemotherapy, Adjuvant
Duration of Therapy
Female
Germany
Humans
Injections, Subcutaneous
Middle Aged
Molecular Targeted Therapy
Neoadjuvant Therapy
Neoplasm Grading
Neoplasm Staging
Polymerase Chain Reaction
Prognosis
Quality of Life
Receptor, ErbB-2
/ antagonists & inhibitors
Retreatment
Trastuzumab
/ administration & dosage
Treatment Outcome
Young Adult
DFS
EFS
HER2-positive
early breast cancer
pCR
safety profile
subcutaneous trastuzumab
Journal
Anticancer research
ISSN: 1791-7530
Titre abrégé: Anticancer Res
Pays: Greece
ID NLM: 8102988
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
30
11
2020
accepted:
15
12
2020
entrez:
9
1
2021
pubmed:
10
1
2021
medline:
26
1
2021
Statut:
ppublish
Résumé
Subcutaneous Herceptin (HER SC) has been shown to be equally effective and safe compared to intravenous Herceptin (HER i.v.) application in early HER2-positive breast cancer (HER2+ BC). However, real-world data from the subcutaneous application are currently limited. Based on a non-interventional study (NIS), data from routine clinical use of HER SC have been gathered between 2013 and 2018 in 135 hospitals and open-care practices throughout Germany. A total of 265 patients were recruited in the neo-adjuvant and 605 patients in the adjuvant setting. Primary effectiveness endpoint in the neoadjuvant treatment setting was pathological complete response rate, which was achieved in 41.5%. Primary endpoint in the adjuvant setting was disease free survival rate after 2 years (94.9%). Safety results from the study were comparable to the well-known safety profile of HER i.v. including preferred terms, incidence, severity, including cardiac events. No new safety signals were detected. Effectiveness and safety of HER SC were comparable to data from HER i.v. in early HER2+ BC.
Sections du résumé
BACKGROUND/AIM
OBJECTIVE
Subcutaneous Herceptin (HER SC) has been shown to be equally effective and safe compared to intravenous Herceptin (HER i.v.) application in early HER2-positive breast cancer (HER2+ BC). However, real-world data from the subcutaneous application are currently limited.
PATIENTS AND METHODS
METHODS
Based on a non-interventional study (NIS), data from routine clinical use of HER SC have been gathered between 2013 and 2018 in 135 hospitals and open-care practices throughout Germany.
RESULTS
RESULTS
A total of 265 patients were recruited in the neo-adjuvant and 605 patients in the adjuvant setting. Primary effectiveness endpoint in the neoadjuvant treatment setting was pathological complete response rate, which was achieved in 41.5%. Primary endpoint in the adjuvant setting was disease free survival rate after 2 years (94.9%). Safety results from the study were comparable to the well-known safety profile of HER i.v. including preferred terms, incidence, severity, including cardiac events. No new safety signals were detected.
CONCLUSION
CONCLUSIONS
Effectiveness and safety of HER SC were comparable to data from HER i.v. in early HER2+ BC.
Identifiants
pubmed: 33419847
pii: 41/1/485
doi: 10.21873/anticanres.14799
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
Biomarkers, Tumor
0
Receptor, ErbB-2
EC 2.7.10.1
Trastuzumab
P188ANX8CK
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
485-496Informations de copyright
Copyright© 2021, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.